Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use". This draft guidance document describes studies and criteria FDA recommends in premarket submissions for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) use by lay-persons. When finalized, FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these device types. This draft guidance is not final nor is it in effect at this time.